Enbrel Approved


May 28, 1999

The Associated Press

WASHINGTON (AP) -- Some of the 50,000 American children who suffer debilitating rheumatoid arthritis won a potent new treatment Friday, the genetically engineered drug Enbrel.
Doctors welcomed the much-needed therapy but warned that it should be reserved for children with moderate to severe arthritis who have failed standard therapy. That's because Enbrel comes with a safety question:
Will it pose a serious risk of infection?
``It is somewhat concerning,创 acknowledged Dr. William Schwieterman of the Food and Drug Administration, which approved Enbrel for children but ordered its maker to continue monitoring that question. But Schwieterman called Enbrel ``very good news创 for children who have had few options. ``It磗 very clear Enbrel is likely to provide a substantial number of them benefit,创 he said.

Immunex Corp. began selling Enbrel for adult rheumatoid arthritis last winter. It attacks the disease in a way no other medicine does, soaking up an immune system protein called tumor necrosis factor that causes much of rheumatoid's inflammation before the substance can reach joints to damage them.

Doctors who treat juvenile rheumatoid arthritis immediately clamored to know if Enbrel would help arthritis' smallest sufferers, too.

The FDA approved Enbrel for children based on a study of 69 moderate to severe patients ages 4 to 17 who failed standard treatment. Enbrel helped 74 percent of them improve.

Katie Emmerson of West Covina, Calif., moved from a wheelchair to the school swimming team after joining the Enbrel study 1 1/2 years ago.  Initially, almost every joint was swollen and painful. She had failed all other therapies and was suffering severe side effects from

``She hadn磘 been able to close her hand in two years, and she made a fist创 48 hours after her first Enbrel injection, mother Patti
Emmerson said. ``I磍l never forget. ... She said, 碝om, I feel so

Today, Katie, 15, requires no other medication.

But the worry is that by inhibiting the immune system, Enbrel could
cause infections.

Two weeks ago, the FDA revealed that 30 of an estimated 25,000 adult Enbrel users have developed serious infections, and six have died. The FDA ordered Immunex to study whether the drug is to blame. Meanwhile, doctors were warned not to give Enbrel to any adults with active or chronic infections, and to be cautious in prescribing it to people with diseases like diabetes that increase infection risk. 

Sixty-two percent of children studied suffered some infection, but all
were mild cases, the FDA said. There's no way to tell if those were just routine childhood infections, but FDA said pediatricians should heed Enbrel's warnings and ordered Immunex to report how all child users fare.

``Kids do get infections multiple times during a year,创 cautioned
Dr. Steven Abramson of the Hospital for Joint Diseases, an expert on
juvenile rheumatoid arthritis for the Arthritis Foundation.

But until doctors learn more about the potential risk, Abramson urged that only children with serious disease who aren't helped by other treatments try Enbrel.

``This is perhaps the most effective drug doctors have seen创 in
years, so they may want to use it widely, Abramson said. ``I would still err on the side of being very conservative."

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